{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "South Jordan",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78961",
      "recalling_firm": "Merit Medical Systems, Inc.",
      "address_1": "1600 W Merit Pkwy",
      "address_2": "N/A",
      "postal_code": "84095-2416",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain",
      "recall_number": "Z-0688-2018",
      "product_description": "PreludeSNAP Splittable Hydrophilic and  non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5",
      "product_quantity": "60,945 devices",
      "reason_for_recall": "Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude  SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.",
      "recall_initiation_date": "20171214",
      "center_classification_date": "20180222",
      "termination_date": "20200710",
      "report_date": "20180228",
      "code_info": "Lot Numbers:  Q1176348  Q1178762  Q1194660  Q1206565  Q1201803  Q1209475  Q1213042  Q1228339  Q1234189X1  Q1234639  Q1182862  Q1190097  Q1194661  Q1197055  Q1202959  Q1213024  Q1215467  Q1234979  Q1174112  Q1197331  Q1176349  Q1213048  Q1182863  Q1228338  Q1194041  Q1206577  Q1214620  Q1184987  Q1194664  Q1213051  Q1237072  Q1213018  Q1205118  Q1175815  Q1194665  Q1197054  Q1193985  Q1193397  Q1209478  Q1228340  Q1176347  Q1204708  Q1182836  Q1170938  Q1161477  Q1185050  Q1234958  Q1176345  Q1193391  Q1228356  Q1175817  Q1194663  Q1215702  Q1228354  Q1201789"
    }
  ]
}